Senior Manager, Global Patient Safety - General Medicine

Location: Tarrytown, New York, or Warren, New Jersey; 4 days per week onsite

Company

hirify.global is a biotechnology company that discovers, develops, and commercializes medicines for serious diseases.

What you will do

• Develop and support safety strategies for molecules in clinical development and post-marketing phases.
• Aggregate, review, and analyze safety data to support safety interpretation and benefit-risk assessment.
• Complete signal detection and evaluate identified signals in line with approved surveillance plans.
• Prepare and review DSURs, PSURs, RMPs, and responses to health authority queries.
• Present findings at Signal Management Team meetings and participate in clinical study team meetings.
• Represent Global Patient Safety on cross-functional committees and contribute to process and SOP improvements.

Requirements

• Master's degree, PhD, or PharmD.
• At least 7 years of relevant risk management experience in the pharmaceutical or biotechnology industry or with a health authority.
• Working knowledge of FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance.
• Experience covering both clinical trial and post-marketing environments.
• Ability to use safety system databases for medical case review and simple queries.
• Strong verbal and written communication, organization, prioritization, and delivery skills.

Culture & Benefits

• Science-driven environment focused on developing life-changing medicines.
• Inclusive workplace and equal opportunity employment.
• Comprehensive rewards may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Many roles are performed onsite to support collaboration.